Phase 2
Completed N=16
A PET Study of the Effects of p38 MAP Kinase Inhibitor, VX-745, on Amyloid Plaque Load in Alzheimer's Disease (AD)
Source: ClinicalTrials.gov NCT02423122 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Percent Change From Baseline in Amyloid Plaque Burden by 11C-PiB PET — -4.57; 4.57 percentage change from baseline
Summary
This study will assess the effects of administration of VX-745 for 12 weeks on amyloid plaque burden in Alzheimer's disease (AD). Subjects who meet entry criteria will undergo 11C-PiB (Carbon-11-labeled Pittsburgh Compound B) positron emission tomography (PET) at baseline and after 45 days of dosing with VX-745. Cognitive testing will also be conducted at baseline and day 45.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Amyloid Plaque Burden by 11C-PiB PET |
-4.57; 4.57 | — |
| PRIMARY Number of 11C-PiB Responders |
3; 1 | — |
| SECONDARY Wechsler Memory Scale (WMS) Immediate Recall Composite |
7.0; 13.4 | — |
| SECONDARY Wechsler Memory Scale (WMS) Delayed Recall Composite |
7.5; 10.4 | — |
Eligibility Criteria
Inclusion Criteria
- Willing and able to provide informed consent
- Diagnosis of mild cognitive impairment (MCI) due to probable AD or of mild AD
- MMSE range: 20 to 28
- Evidence of amyloid pathology by amyloid PET scan
- Participants may be taking medications for AD, provided that the dose of these medications has been stable for >3 months
- Proficiency in Dutch and adequate visual and auditory abilities to be able to perform all aspects of the cognitive and functional tests
- Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments.
Exclusion Criteria
- Evidence of neurodegenerative disease other than AD
- Inability for any reason to undergo PET and fMRI scans (including notably: history of allergic reaction of any severity to 11C-PiB injection; pacemaker, vascular stent or stent graft)
- Psychiatric disorder that would compromise ability to comply with study requirements
- Significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder or metabolic/endocrine disorders or other disease that would preclude treatment with p38 MAP kinase inhibitor and/or assessment of drug safety and efficacy
- Recent (<90 days) changes to AD medications prescribed for cognitive reasons or with the potential to impact cognition
- Participation in a study of an investigational drug less than 6 months or 5 half-lives of the investigational drug, whichever is longer, before enrollment in the study
- Male subjects with female partner of child-bearing potential who are unwilling or unable to adhere to contraception requirements
- Female subjects who have not reached menopause or have not had a hysterectomy or bilateral oophorectomy/salpingoophorectomy
- Positive urine or serum pregnancy test or plans desires to become pregnant during the course of the trial
- Any factor deemed by the investigator to be likely to interfere with study conduction
Data sourced from ClinicalTrials.gov (NCT02423122). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.